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"China's pharmaceutical innovation will be in the follow-on stage
for a long time.
"
"Fortunately, this kind of Follow has advanced from the slow follow of the past to the current Fast Follow
.
"
Indeed, the current follow-up of domestic innovative drugs has shifted from following the research and development of overseas marketed drugs in the past to those FIC drugs
that are in the clinical stage or even preclinical research with new targets and new technologies.
The faster you follow, the better
your chances.
Chinese pharmaceutical companies are increasingly appearing in the first echelon of
global research and development.
But the tighter you follow, the greater
the risk.
The development of the world's first PD-LI/TGF-β bifunctional fusion protein M7824, once known as the second-generation PD-1, has been terminated, and the Fast Follow that has entered the clinic at this target includes more than ten Chinese companies including Hengrui, Chia Tai Tianqing, and Qilu;
Roche's star target TIGIT has "stepped down from the altar" due to a number of clinical failures to meet expectations, which has sharply increased the pressure on Baekje, which is in the second place in global research and development and has a potential value of up to $2.
8 billion.
The FDA's almost comprehensive "say no" dilemma for P13K inhibitors has made domestic pharmaceutical companies with the same target drugs nervous.
.
.
Fast Follow is often seen as standing on the "shoulders of giants" of the First-in-Class with higher druggability, relatively reduced risk, and shorter
R&D cycles.
But if the "giant" falls, the followers on the shoulders will also fall into an embarrassing situation
.
When China's pharmaceutical innovation is still dominated by Fast Follow on in the future, how far should pharmaceutical companies "follow" up? When there are problems in the development of the followed FIC or after marketing, how can the follower avoid risks?
01 How to follow a good follower?
What makes a good follower? "In fact, iterative innovation represented by me too and me better is the mainstream of current global innovative drugs, such as Lipital, Keytruda and adalimumab, etc.
, and many of the drugs with high global sales in the past or now are Fast Follow, not First-in-Class
.
" BeiGene President Wu Xiaobin said
this in a previous interview with E drug managers.
For the vast majority of domestic innovative pharmaceutical companies, "Fast Follow" is the easiest and most effective way to
realize their own value monetization.
Choosing to follow FIC and become a Fast Follower and achieving breakthroughs through differentiated research is a faster path
.
For the followers on the shoulders of giants, some investors pointed out that the druggability of "Fast Follow" drugs has been greatly improved, the risk of failure has been reduced, the time period of research and development has also been shortened, and the requirements for talents and funds have been relatively reduced, but the unavoidable problem is that now the domestic Fast Follow has fallen into serious involvement
.
"It's too floating!" An overseas R&D personnel of a local innovative pharmaceutical company lamented that there is a common phenomenon in today's domestic pharmaceutical companies, once they see a target hot, they will rush to it, but the basic research of some projects is not solid, blindly pursuing Fast, and eventually becoming Me-worse
.
At the same time, even as a follower, you need to face the risk of failure in the research and development of new drugs, basic research is not solid, too homogeneous copying work, once a target FIC project encounters a "roadblock", only care about the follower of the copying operation is also easy to "die"
.
Even if a new drug has gone through a long research and development period, or even passed the rapid review and went to market, there are many cases of drugs that are eventually withdrawn or included in the discussion by the FDA, such as PI3K inhibitors that were withdrawn from their indications not long ago and PAPP inhibitors
that were included in the discussion at the ODAC meeting.
"New drugs must tolerate risks in order to discover new opportunities
.
" R&D personnel who have experienced 10 years of new drug research and development told E drug managers that even if there are twists and turns in the development of foreign original drugs, Fast Follow companies often do not modify their strategies
at will.
"Once you choose to become Fast Follow, slowing down because of risk can lead to a higher failure rate
.
If it is for a project that has not yet been clinically validated, although the corresponding risks should be considered, it is possible to catch up with the followee in the short term due to their failure
.
Of course, if you choose to do me-better in Fast Follow, you don't necessarily need time to catch up so tightly, as long as you can develop better drug molecules, you are also expected to defeat your opponents
after marketing.
For the strategic layout of Fast Follow, many industry insiders interviewed by E drug managers believe that R&D uncertainties are widespread, risks and benefits coexist, and the company's strategy is closely linked, but the risks need to be within the expected range
.
When choosing Fast Follow or other strategies, companies have taken into account the failure rate and other risks
of various strategies.
As a decision-maker in a company, you should consider when to stop, what adjustments to make, and analyze the results are also crucial
.
Liu Liu, CMO of Yachuang Pharmaceutical, confirmed that firmly taking the road of innovation will not change
.
Even as a follower, you must do solid basic research and look for differentiated breakthroughs
.
He pointed out that the concept of corporate decision-makers, in particular, should be changed, following is the fear of failure, the reason for fear of failure is to be safe, but if there is no difference in copying work, how much can be gained? Chen Xiaomin, COO of Amador Biologics, believes that without differentiated Fast Follow, even if it enters the market, it cannot be converted into huge value, so the post-listing situation should be considered when setting up a project, rather than "setting up a project for the sake of project establishment"
.
What exactly does Fast Follow do? The above-mentioned R&D personnel also gave their own vision, and the ideal industrial structure should have differentiated sectors
.
"The best path for new drug development is to build a new drug landscape in a way that is more specialized in the industry and improves the overall original innovation, but the growth of this prospect will take time
.
" Some industry analysts believe that for example, some companies can focus on Fast Follow, develop products that can meet the needs of local pharmaceutical markets with a fast enough research and development speed, and can also reduce the cost
of drugs for local patients.
The fight and competition between this sector will produce some large-scale and relatively excellent enterprises
in the sector.
Others focus on more innovative areas, such as the mature industrial chain model between overseas biotech and bigpharma, "companies specializing in incubation will start communicating with professors from the university to complete the stage
from incubation to clinical phase I.
" After entering Phase I, companies specializing in clinical trials will take over, and when clinical trials enter Phase II-III, they may begin to sell products to big pharma or choose to IPO
.
Some investors once said to the manager of E drug, "This is normal, such a division of labor in the European and American markets has been very clear, but at present, this form in China is still in the process of
gradually forming.
" ”
02 How fault-tolerant is the market?
How fault-tolerant is the market? Fast Follow should not be a topic of discoloration, whether it is biased towards "First-in-Class" or the pursuit of "Fast Follow", it is a strategic choice
made by different enterprises to quickly maximize their own value and interests according to their own capabilities, funds, markets and other factors.
In a self-developed way, it is related to phase I, phase II or preclinical, or through license in the introduction of mid-to-late stage or overseas listed products or even directly buy a biotech company, the degree and way of follow-up are very related
to the layout of different companies' therapeutic areas, research and development strength, and cash flow.
For companies with sufficient cash flow, the introduction of external product pipelines by license-in is a way
to quickly supplement their own R&D layout compared to going through a 10-year R&D cycle.
The person in charge of many pharmaceutical companies BD said that many domestic pharmaceutical companies have paid attention to projects in the middle and late stages of clinical practice, and even have been listed in some regions, which not only achieves rapid follow-up, but also relatively lower
research and development risks.
However, the challenges of uncertainty remain enormous
.
Hengrui, which had rarely licensed in the past, was rejected by Plinabulin in the FDA, and was "ridiculed" for its lack of
BD capabilities.
Wang Yu, an investor who has been following the pharmaceutical market for a long time, said that although the domestic investment and financing environment is not so pessimistic, many investors are not mature and do not tolerate
innovation failure.
"We generally rarely go with phase I projects, and phase I does exist without a proof of concept, only some preliminary data and a small number of cases, which is really risky
.
" BD, an innovative pharmaceutical company, said that the comprehensive evaluation ability of the BD team and the understanding of the biological mechanism of the target are also very important, "If the requirements are stable, try to lean back and buy the company directly, but this is more suitable for companies with
deep pockets.
" There are also BDs who give such advice
.
Of course, on the contrary, there are BDs who prefer to focus on the earliest projects, "this type of project does not invest a lot of money in the early stage, even if it encounters failure, it is within a certain range
.
" For these two "extremes", BD bluntly said that different companies have different fault tolerance and risk tolerance, license-in projects, research and development failures or accidents, for some companies, is a big thing, but some companies will understand that this is a "normal thing"
.
For the risks arising from the follow-up of the introduction project, some pharmaceutical company BD gave suggestions to avoid the large losses caused by R&D failure or rejection of approval
.
On the one hand, it is clearly stated in the introduction authorization clause that if the FDA and other regulatory agencies refuse to approve for some reason, especially the factors of concealment and non-reporting, it is a breach
of principle involving significant compensation.
On the other hand, when paying for milestones, try to press
the node backwards.
"This is the current common practice, put a little less in the early stage, and put a little
more after the listing.
"
A number of respondents told E drug managers that the current domestic innovation environment, whether it is self-research or introduction, is not so tolerant of research and development failures
.
"It's about the maturity and experience of
the industry, the market.
" The person in charge of a domestic investment institution said that overseas markets are more familiar with the process and risks of new drug development, and the ways and exit mechanisms of primary and secondary capital markets will be more flexible and diverse
.
In the event of project R&D failure or obstruction, if the enterprise itself has a certain cash flow hematopoietic capacity, it will be affected in the short term and can recover in the long run
.
However, if for enterprises with poor anti-risk ability, coupled with the company's own lack of license-out and product commercialization hematopoietic ability, the risk in the license-in process may have a great or even critical impact on
the company's cash flow.
As a result, rational business decision makers generally don't place all their bets on
a single product.
03 Regulation should also be Fast Follow
Regulation should also be Fast Follow In the past, products that have been listed in China or are in the process of marketing application have often been clinically and used overseas for many years, and both safety and efficacy have been verified
.
As local innovative drugs continue to close the research progress and marketing approval time lag with overseas FIC drugs, the era of expanding new indications and combination therapies on the basis of the original indications, and exploring new targets and technologies for original innovation has arrived
.
This also puts forward higher requirements
for domestic drug review, approval and supervision.
"The impact of the review of similar drugs abroad on domestic projects may indeed lead to the failure
of a drug that is following.
" A pharmaceutical company R&D personnel told the
E drug manager.
When the PI3K inhibitor duvelise was withdrawn by the FDA last month, some insiders were worried that CSPC's PI3K inhibitor had been marketed in China, but after the FDA's Oncology Drug Advisory Committee (ODAC) "said no" to the approval of PI3K inhibitors in single-arm trials, it is still unknown
whether domestic regulators will require Duvelise to increase clinical trials 。 In this regard, some clinical pharmacologists told E drug managers that although the FDA's meeting decisions will not necessarily have a direct impact on domestic marketed drugs, relevant pharmaceutical companies should also pay attention to it, in the face of changes in overseas supervision, approved drugs are likely to need to add or modify the warning of the instructions to remind them of adverse reactions, and the development of subsequent indications in China may also be strictly limited
.
As the market with the highest level of innovation in the world, the regulatory agencies represented by the FDA are constantly rethinking and improving the new drug review and approval mechanism
in the face of the world's leading new technologies and new targets.
For example, in the FDA, there are 18 advisory committees on human drugs
.
Although the recommendations of such advisory committees do not have legal effect, FDA mostly adopts the
recommendations of the advisory committees.
According to previous data, compared with the opinions of 376 advisory committee meetings and FDA resolutions held between 2008 and 2015, the FDA adopted 78% of the advisory committee recommendations
.
"From the current point of view, although there is no mechanism in China to vote on the market or withdraw a drug through an external consultation meeting, with the improvement of the level of domestic innovation, it is not ruled out that similar institutions
will appear.
" Some clinical pharmacologists believe that the content discussed at each FDA ODAC meeting and the voting results after the meeting are broadcast live and transparent, and the experts participating in the voting are screened for qualifications and signed opinions are published
online.
The whole conference process is open and transparent, and the problems pointed out in the meeting can often be learned and used for subsequent clinical research, avoiding detours by "latecomers"
.
"In this way, the failure of Innovent PD-1 to go to sea has become a case
that pharmaceutical companies must conduct in-depth research and analysis when they go abroad.
" The organization of such advisory committees, open information, and transparent views are all beneficial to pharmaceutical companies
.
In the current environment of the rise of innovative drugs in China, pharmaceutical companies and regulators are "Fast Follow"
.
"A lot of the CDE system is learned from the FDA
.
" The person in charge of oncology medical affairs of a pharmaceutical company said
.
In the face of the continuous emergence of new targets and technologies in the industry, domestic drug regulatory agencies are also facing challenges
.
A number of respondents said that pharmaceutical companies closely follow the international frontier of pharmaceutical innovation, and regulators are learning from the relevant experience of the FDA, improving the communication and exchange system, and jointly exploring and solving regulatory challenges brought by new technologies and new targets with pharmaceutical companies to help the research and development
of new drugs.
